CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS Phase: IV TITLE OF STUDY Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery CONDITION Peripheral arterial occlusive disease (PAOD) OBJECTIVE(S) The objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery. INTERVENTIONS Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). Duration of intervention per patient: Dependent on the method of treatment Follow-up per patient: 24 months OUTCOMES Primary efficacy endpoint: Two primary efficacy endpoints will be considered simultaneously in this trial: (A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of \>= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR). (B) Proportion of surviving patients with clinical improvement of \>= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).
Study Type
OBSERVATIONAL
Enrollment
470
Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).
Medizinische Universität Innsbruck
Innsbruck, Austria
NOT_YET_RECRUITINGWilhelminenhospital Wien
Vienna, Austria
NOT_YET_RECRUITINGUniversitätsklinikum Aachen
Aachen, Germany
NOT_YET_RECRUITINGKlinikum Augsburg
Augsburg, Germany
NOT_YET_RECRUITINGKlinikum am Bruderwald
Bamberg, Germany
NOT_YET_RECRUITINGBundeswehrkrankenhaus Berlin
Berlin, Germany
NOT_YET_RECRUITINGUniklinik Bonn
Bonn, Germany
NOT_YET_RECRUITINGKlinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main
Frankfurt am Main, Germany
NOT_YET_RECRUITINGUniversitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin
Hamburg, Germany
NOT_YET_RECRUITINGKlinikum Hanau
Hanau, Germany
NOT_YET_RECRUITING...and 15 more locations
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.